第一代 EGFR-TKI 联合贝伐珠单抗和化疗治疗晚期 EGFR 突变型非鳞状非小细胞肺癌：一项回顾性研究。

First-generation EGFR-TKI plus bevacizumab and chemotherapy for advanced EGFR-mutated non-squamous non-small-cell lung cancer: a retrospective study.

机构信息

Department of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, Fujian, China.

Department of Medical Oncology, Chongqing University Cancer Hospital, Chongqing, China.

出版信息

Ann Med. 2023;55(2):2243967. doi: 10.1080/07853890.2023.2243967.

BACKGROUND

This study aimed to compare the efficacy and safety of different treatment modalities for previously untreated advanced EGFR-mutated non-squamous non-small-cell lung cancer (NSCLC).

METHODS

This retrospective study included 196 advanced EGFR-mutated non-squamous NSCLC. 107 received EGFR-tyrosine kinase inhibitor (EGFR-TKI) monotherapy (T), 53 received EGFR-TKI + bevacizumab (T + A), and 36 received EGFR-TKI + bevacizumab + chemotherapy (T + A + C). The endpoints included progression-free survival (PFS), overall survival (OS), objective response rate (ORR) and adverse events (AEs).

RESULTS

The median PFS was 27 months in the T + A + C group, 17 months in the T + A group, and 10 months in the T group. The multivariate analysis showed lower disease progression in the T + A + C group (HR, 0.377; 95% CI, 0.224-0.634; < .001). Subgroup analysis showed that the T + A + C group did significantly improve PFS in patients with metastatic organs ≥2, brain metastases, liver metastases, and EGFR 19del compared to T + A group. No significant improvement in OS in the T + A + C group versus the T + A group, but a significant benefit in the subgroup of patients with metastatic organs ≥2. We also performed a subgroup analysis of the T + A + C group versus the T group, which similarly showed that the T + A + C group had better PFS than the T group in most subgroups, and the T + A + C group significantly improved OS in patients with metastatic organ ≥2 and liver metastases compared with the T group. The ORR was significantly higher in the T + A + C group than A + T and T groups (83.3% vs 71.7% vs 60.7%, = .033). In safety, the T + A + C group had a higher incidence of AEs, but the majority was grade 1-2. The most frequent AEs of grade ≥ 3 were leukopenia (8.3%) and increased aminotransferase (8.3%) in the T + A + C group.

CONCLUSIONS

First-generation EGFR-TKI plus bevacizumab plus chemotherapy was a promising strategy for advanced EGFR-mutated non-squamous NSCLC.

背景

本研究旨在比较初治晚期 EGFR 突变型非鳞状非小细胞肺癌（NSCLC）的不同治疗方法的疗效和安全性。

方法

本回顾性研究纳入了 196 例初治晚期 EGFR 突变型非鳞状 NSCLC 患者。107 例接受 EGFR 酪氨酸激酶抑制剂（EGFR-TKI）单药治疗（T 组），53 例接受 EGFR-TKI+贝伐珠单抗（T+A 组），36 例接受 EGFR-TKI+贝伐珠单抗+化疗（T+A+C 组）。终点包括无进展生存期（PFS）、总生存期（OS）、客观缓解率（ORR）和不良事件（AEs）。

结果

T+A+C 组的中位 PFS 为 27 个月，T+A 组为 17 个月，T 组为 10 个月。多变量分析显示，T+A+C 组疾病进展风险较低（HR，0.377；95%CI，0.224-0.634； < .001）。亚组分析显示，与 T+A 组相比，T+A+C 组在转移性器官≥2、脑转移、肝转移和 EGFR 19del 患者中 PFS 显著改善。与 T+A 组相比，T+A+C 组的 OS 无显著改善，但在转移性器官≥2 的患者亚组中获益显著。我们还对 T+A+C 组与 T 组进行了亚组分析，结果类似，T+A+C 组在大多数亚组中 PFS 优于 T 组，T+A+C 组在转移性器官≥2 和肝转移的患者中 OS 显著改善与 T 组相比。与 T+A 组相比，T+A+C 组的 ORR 显著更高（83.3%比 71.7%比 60.7%， = .033）。在安全性方面，T+A+C 组 AEs 发生率较高，但大多数为 1-2 级。最常见的 3 级以上 AEs 为白细胞减少症（8.3%）和氨基转移酶升高（8.3%）。